Short Course Radiation Treatment for Patients With Primary or Locally Recurrent Retroperitoneal Sarcoma Prior to Surgery

Prospective Phase I Trial of Hypofractionated Radiation Therapy in Retroperitoneal Sarcoma

To determine the safety of moderately hypofractionated radiation in the treatment of primary and locally recurrent RPS, based on the evaluation of acute radiation-related toxicity profile of each participant (30-day radiation toxicity)

Study Overview

• Status: Recruiting
• Conditions: Retroperitoneal Sarcoma
• Intervention / Treatment: Radiation: Radiation Therapy; Radiation: Hypofractionationed Radiation Therapy

Detailed Description

To determine the safety of moderately hypofractionated radiation in the treatment of primary and locally recurrent RPS, based on the evaluation of acute radiation-related toxicity profile of each participant (30-day radiation toxicity)

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Miranda Lam; Phone Number: 617-732-7948; Email: miranda_lam@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02446
      • Recruiting
      • Brigham and Women's Hospital / Dana Farber Cancer Institute
      • Contact: Miranda Lam; Phone Number: 617-732-7948; Email: miranda_lam@dfci.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

Patients with retroperitoneal sarcoma who have been recommended to receive pre-operative radiation therapy followed by surgery

Description

Inclusion Criteria:

• Participants must have a histologically confirmed STS of the retroperitoneal space or infra-peritoneal spaces of pelvis
• Participant must have radiologically measurable disease (RECIST 1.1), as confirmed by abdomino-pelvic CT or MRI
• Participant must have primary, locally recurrent, or metastatic disease requiring treatment of the retroperitoneal mass
• Tumor must be suitable for radiotherapy and surgery based on pre-treatment CT scan/MRI in multidisciplinary discussion with surgeon and radiation oncologist (anticipated macroscopically complete resection, R0/R1 resection)
• Age: 18 years or older
• ECOG performance status ≤2
• Absence of history of bowel obstruction, mesenteric ischemia, or severe chronic inflammatory bowel disease.
• Normal renal function (calculated creatinine clearance ≥50 mL/min)
• Normal bone marrow and hepatic function (white blood cell count ≥2·5 × 10⁹ cells per L, platelet count ≥80 × 10⁹ cells per L, and total bilirubin <2 times upper limit of normal)
• Women of child-bearing potential must have a negative pregnancy test within 3 weeks prior to the first day of study treatment
• Patients capable of childbearing/reproductive potential should use adequate contraception
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Sarcoma originating from bone structure, abdominal or gynecological viscera
• Any of the following histological subtypes: gastrointestinal stromal tumor, rhabdomyosarcoma, primitive neuroectodermal tumor or other small round blue cell sarcoma, osteosarcoma, chondrosarcoma, aggressive fibromatosis, or sarcomatoid or metastatic carcinoma
• Prior RT to the RPS
• Prior abdominal or pelvic irradiation for other prior malignancy or other disease
• Prior different invasive malignancy may be eligible per the discretion of the treating investigator and review by the Principal Investigator (PI)
• Prior chemotherapy or immunotherapy within 6 weeks of start of RT
• Pregnant women are excluded from this study because RT has the potential for teratogenic or abortifacient effects.
• HIV-positive individuals on combination antiretroviral therapy are ineligible because of the potential for increased sensitivity to RT

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hypofractionated Radiation Therapy; This group is receiving hypofractionated radiation therapy (shorter course of radiation therapy)

Radiation: Radiation Therapy; In this study, patients will receive a hypofractionated course of radiation therapy of 2.85 Gy x 15 fractions (42.75 Gy). If there are 2 or more patients with dose-limiting toxicities, the radiation course will be de-escalated to 2.7 Gy x 15 fractions (40.5 Gy).; Radiation: Hypofractionationed Radiation Therapy; This group is receiving hypofractionated radiation therapy (shorter course of RT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects from radiation therapy	Evaluation of acute radiation-related toxicity profile of each participant, specifically nausea, vomiting, diarrhea, and other gastrointestinal (GI) side effects.	From enrollment to 30-days after the completion of radiation treatment

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Miranda Lam, Dana-Farber/Brigham and Women's Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: January 27, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): February 6, 2025

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 11, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Sarcoma; Therapeutics; Radiotherapy
• Other Study ID Numbers: 24-450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No